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Genetic toxicity: in vitro

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Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Remarks:
Type of genotoxicity: gene mutation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Oct 31, 1990 to Dec 31, 1991
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study performed according to international guidelines and Good Laboratory Practice standards using the comemercial product as test article.

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1991
Reference Type:
publication
Title:
Methods for detecting carcinogens and mutagens with the Salmonella/mammalian-microsome mutagenicity test.
Author:
Ames et al.
Year:
1975
Bibliographic source:
Mutation Research 31:347-364.
Reference Type:
publication
Title:
Simple bacterial systems for detection mutagenic agents
Author:
Bridges BA
Year:
1972
Bibliographic source:
Laboratory Practice 21:413-419.
Title:
Revised methods for the Salmonella mutagenicity test
Author:
Maron DM, Ames BN.
Year:
1983
Bibliographic source:
Mutat Res. 1983 May;113(3-4):173-215.
Reference Type:
publication
Title:
Unnamed
Year:
2007

Materials and methods

Principles of method if other than guideline:
Ames et al. (1975); Maron and Ames (1983), Bridges (1972).
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
96.3% Decabromodiphenyl ethane
3.6 % Dodecabromodiphenyl ethane

Method

Species / strain
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Additional strain / cell type characteristics:
other: TA1538 and E. coli uvrA was also included
Metabolic activation:
with and without
Metabolic activation system:
Arochlor-induced rat liver microsomes
Test concentrations with justification for top dose:
0, 333, 667, 1000, 333 and 5000 ug/plate
Vehicle / solvent:
dimethylsulfoxide
Details on test system and experimental conditions:
Test article tested at 5 dose levels with appropriate vehicle and positive controls in the presence and absence of microsomal activation. All dose levels of the test article, vehicle controls and positive controls were plated in triplicate. A second confirmatory asssay was performed.
Evaluation criteria:
To be positive, a test article must cause a dose-related increase in the mean revertants per plate of at least one tester strain with a minimum of two increasing concentrations of test article:
Strains TA1535, TA1537, TA1538: data sets judged positive if the increase in mean revertants at the peak of the dose response is equal to or greater than three times the mean vehicle control value.
Strains TA98, TA100, and WP2 uvrA: data sets judged positive if the increase in mean revertants at the peak of the dose response is equal to or greater than two times the mean vehicle control value.
Statistics:
Mean number of revertants/plate and standard deviation of the means.

Results and discussion

Test results
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity, but tested up to precipitating concentrations
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Additional information on results:
No increase in revertant colonies was found at any dose level in the presence or absence of microsomal enzymes in either Salmonella or E. coli.
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative

The test article did not induce mutations.
Executive summary:

In the Ames assay, the tester strains used wereSalmonellaTA98, TA100, TA1535, TA1537, and TA1538, andE. coliWP2 uvrA (WP2A). Each strain was tested with and without a source of exogenous metabolic activation of Arochlor-induced rat liver microsomes. The dose levels were 0, 333, 667, 1000, 3333 and 5,000 ug/plate. Appropriate positive and negative controls were included. An independent re-test was included. No increase in revertant colonies was found at any dose level in the presence or absence of microsomal enzymes.